Diphenhydramine HCl
Akron Pharma, Inc.
3c323dc8-f734-b44c-e063-6394a90a6184
HUMAN OTC DRUG LABEL
Aug 12, 2025
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each banded capsule)
Diphenhydramine Hydrochloride 25 mg and 50 mg
OTC - PURPOSE SECTION
Purpose
Antihistamine
WARNINGS SECTION
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- take every 4 to 6 hours
- do not take more than 6 doses in 24 hours
25 mg Dosage:
|
Age |
Dose |
|
adults and children 12 years and over |
1 to 2 capsules |
|
children 6 to under 12 years of age |
1 capsule |
|
children under 6 years of age |
do not use this product in children under 6 years of age |
50 mg Dosage:
|
** Age** |
** Dose** |
|
adults and children 12 years and over |
1 capsules |
|
children under 12 years of age |
ask a doctor, the proper dosage |
**Do not attempt to break capsules. The proper dosage strength and dosing
information for children under 12 years of age is available on the
25 mg. package.
STORAGE AND HANDLING SECTION
Other information
- store at temperature 15° to 30° C (59° to 86°F)
- do not use if either capsule band or imprinted safety seal under cap is broken or missing
- protect from moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients
Colloidal silicon dioxide, Gelatin, Lactose Monohydrate, Magnesium Stearate, Microcrystalline cellulose
OTC - QUESTIONS SECTION
Questions or comments?
Call toll-free 1-877-225-6999
Manufactured for:
Akron Pharma, Inc,
373 RT US 46 W, Building E,
Suite 117, Fairfield, NJ 07004